A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis

May 23, 2008 updated by: Cognition Pharmaceuticals, LLC

A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment

The purpose of this study is to determine the safety and efficacy of C105 in treating the cognitive deficits that can occur due to multiple sclerosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Saint Joseph's Hospital, Barrow Neurology Clinics
      • Tuscon, Arizona, United States, 85741
        • Northwest Neuro Specialists, PLLC
    • California
      • Lancaster, California, United States, 93534
        • Research Center for Clinical Studies West
      • Loma Linda, California, United States, 92354
        • Loma Linda University, Department of Neurology
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Associated Neurologists, P.C.
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologist of Southern Connecticut, PC
      • New Haven, Connecticut, United States, 06510
        • Yale University MS Center
    • Florida
      • Maitland, Florida, United States, 32751
        • Neurology Associates, PA
      • Sarasota, Florida, United States, 34233
        • Lovelace Scientific Resources
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates, Inc.
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepard Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center, Department of Neurology
      • Lenexa, Kansas, United States, 66214
        • MidAmerica Neuroscience Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System, Department of Neurology
      • Traverse City, Michigan, United States, 49684
        • Northern Michigan Neurology
    • New York
      • Buffalo, New York, United States, 14203
        • The Jacobs Neurological Institute
    • North Carolina
      • Raleigh, North Carolina, United States, 17607
        • Raleigh Neurology Associates
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Meritcare Neuroscience Clinic
    • Ohio
      • Akron, Ohio, United States, 44302
        • Neurology & Neuroscience Associates, Inc.
      • Cincinnati, Ohio, United States, 45242
        • Riverhills Healthcare, Inc
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • The Neurology Foundation, Inc.
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology
      • San Antonio, Texas, United States, 78229
        • Integra Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia, Department of Neurology
      • Richmond, Virginia, United States, 23230
        • Neurological Associates, Inc
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Capitol Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males/females at least 18 years old and < 65 years old, capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education
  • Clinically definite diagnosis per McDonald criteria of Multiple Sclerosis as confirmed by the Investigator (Relapsing-Remitting or Secondary Progressive)
  • Stable disease and relapse-free for > 90 days as verified by Investigator
  • Presence of cognitive deficit as measured score of -1.5 SD on the SDMT (oral version) or a score of -1.0 SD on the SDMT and -1.0 SD on either CVLT-II (total learning or delayed recall) or PASAT
  • EDSS <= 6.5
  • Standard score of >79 on the WRAT-4 Reading test
  • Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
  • Capable of performing the requirements of a neuropsychological test battery including having at least 20/70 near visual acuity by near vision chart, with correction (i.e., eyeglasses) allowed
  • If female, must neither be pregnant nor breast-feeding and she must either (a) be > 12 months post-menopausal or surgically sterilized or (b) must agree to use an acceptable method of birth control (including hormonal contraceptives, intra-uterine device, or barrier methods such as condoms, diaphragm, etc. with spermicide) for the duration of the study. Abstinence will not be considered an acceptable method of birth control.

Exclusion Criteria:

  • Subjects with memory deficits caused by concomitant medication usage or other significant neurological/psychological disease, e.g., Alzheimer's disease, Parkinson's disease, stroke, TIA, Multi-infarct dementia, Huntington's disease, head trauma, or chronic CNS infection
  • Evidence of other medical cause of dementia
  • Evidence of Major Depressive Disorder as determined by a Beck Fast Screen core of >3 and clinician interview
  • Use of the following medications: Antipsychotic agents, Centrally acting appetite suppression drugs (e.g., sibutramine), CNS stimulants or drugs that metabolize to them (e.g., amantadine, Concerta, methylphenidate, Adderall, ephedrine, selegiline), Strattera (atomoxetine), Tricyclic antidepressants (e.g., amitriptyline), Herbal preparations including Ginkgo Biloba or containing Ephedra or other stimulants, MAO inhibitors. Note: other medications may be excluded or permitted, depending on length of treatment and stability of dose
  • Uncontrolled or labile hypertension, or any clinically significant, unstable, or major concomitant disorder as determined by the Principal Investigator
  • Active malignancy within one year of study participation
  • Known human immunodeficiency virus (HIV)
  • Current diagnosis of unstable glaucoma
  • History of myocardial infarction of symptomatic Coronary Artery Disease
  • Evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG
  • History of epilepsy or other seizure disorders
  • Clinically significant motor or speech residual neurological deficits (e.g., hemiparesis, aphasia) that interfere with completion of study procedures
  • Baseline clinical laboratory values indicative of a clinically significant co-morbidity
  • Significant recent history of (within past 12 months) or current drug or alcohol abuse (as defined by DSM-IV)
  • Known allergy or hypersensitivity to amphetamines or other sympathomimetic amines
  • Participation in any clinical trial with an investigational drug within 30 days prior to randomization
  • In the opinion of the Principal Investigator should not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct
Time Frame: Change from baseline
Change from baseline
Subject's Global Assessment of Cognitive Change
Time Frame: Change from baseline
Change from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cognition Pharmaceuticals, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frederick Munschauer, MD, SUNY Buffalo
  • Principal Investigator: Ralph Benedict, PhD, SUNY Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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